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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC PEDIATRIC FLOW PROBE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH EM-TEC PEDIATRIC FLOW PROBE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-30105
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2020
Event Type  malfunction  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that there was a flow of 0. 47 lpm when the centrimag (cmag) system was not turned on and there is no flow. The cmag flow probe was connected to a backup cmag system, and the problem continued. The flow probe was then switched with the a different flow probe with the same console. This resolved the issue.
 
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Brand NameEM-TEC PEDIATRIC FLOW PROBE
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key9713050
MDR Text Key180194600
Report Number2916596-2020-00838
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K020271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30105
Device Catalogue Number201-30105
Device Lot Number6480352
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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